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FDA 510(k)

7 mm Extended Length Endoscope

K-Number: K191930 · 2020-04-15

ApplicantMaquet Cardiovascular, LLC
Decision Date2020-04-15
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

7 mm Extended Length Endoscope is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2020-04-15 under 510(k) number K191930. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7 mm Extended Length Endoscope?

7 mm Extended Length Endoscope is a medical device that received FDA 510(k) clearance on 2020-04-15. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K191930.

When did 7 mm Extended Length Endoscope receive FDA 510(k) clearance?

7 mm Extended Length Endoscope received FDA 510(k) clearance on 2020-04-15, under 510(k) number K191930.

Who is the listed applicant for 7 mm Extended Length Endoscope?

The FDA 510(k) record lists Maquet Cardiovascular, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7 mm Extended Length Endoscope?

The FDA product code for 7 mm Extended Length Endoscope is GCJ.

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Other records listing Maquet Cardiovascular, LLC as applicant

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Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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